Class III · Low risk Terminated
Atorvastatin Calcium Tablets, 40 mg*, packaged as a) 90-count bottle (NDC 55111-123-90 and b) 500-count bottle (NDC…
Reason Failed Impurities/Degradation Specifications
Is Atorvastatin recalled?
67 FDA recalls mention Atorvastatin. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Atorvastatin.
Class III · Low risk Terminated
Atorvastatin Calcium Tablets, 20 mg*, 90-count bottle, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409…
Reason Failed Impurities/Degradation Specifications
Class III · Low risk Terminated
Atorvastatin Calcium Tablets, 10 mg*, 90-count bottle, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409…
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Terminated
Atorvastatin Calcium Tablets, 80 mg*, 90-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409…
Reason Presence of Foreign Substance: A product complaint was received for a defective tablet with an embedded foreign object observed in a bottle.
Class III · Low risk Terminated
Atorvastatin Calcium Tablets 40 mg, 90 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd., Srikakulam, INDIA --- NDC…
Reason Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability
Class III · Low risk Terminated
Atorvastatin Calcium Tablets 20 mg, a) 90 count and b) 500 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd…
Reason Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability
Class III · Low risk Terminated
Atorvastatin Calcium Tablets 10 mg, a) 90 count and b) 500 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd…
Reason Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability
Class II · Moderate risk Terminated
FOR EXPORT ONLY Atorvastatin calcium Film-Coated Tablets a) 80 mg SMT Tabs Bulk, b) 40 mg SMT G EP PR KR, c) 20 mg SMT G EP PR…
Reason Microbial Contamination of Non-Sterile Products
Class II · Moderate risk Terminated
Atorvastatin Calcium Tablets, 10 mg*, 100-count Unit Dose Tablets (10 x 10) per carton, Rx only, Manufactured by: Mylan…
Reason Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
Class II · Moderate risk Terminated
Atorvastatin Calcium Tablets, 80 mg*, packaged in a) 90-count bottles (NDC 0378-3953-09) and b) 500-count bottles (NDC…
Reason Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
Class II · Moderate risk Terminated
Atorvastatin Calcium Tablets, 40 mg*, packaged in a) 90-count bottles (NDC 0378-3952-09) and b) 500-count bottles (NDC…
Reason Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
Class II · Moderate risk Terminated
Atorvastatin Calcium Tablets, 20 mg*, packaged in a) 90-count bottles (NDC 0378-3951-09) and b) 500-count bottles (NDC…
Reason Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
Class II · Moderate risk Terminated
Atorvastatin Calcium Tablets, 10 mg*, packaged in a) 90-count bottles (NDC 0378-3950-77); b) 90-count bottles (NDC 0378-3950-09)…
Reason Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
Class II · Moderate risk Terminated
Atorvastatin Calcium 40mg Tablet, 30-count bottles, Rx only, Pk By Safecor Health Woburn, MA 01801, NDC 60505258009
Reason CGMP Deviations
Class III · Low risk Terminated
Atorvastatin Calcium 80 mg, 10 tablets per blister,100-count package, Rx Only Manufactured by Apotex Inc. Toronto, Ontario…
Reason Failed Impurities/Degradation Specifications
Class III · Low risk Terminated
Atorvastatin Calcium 40 mg, 10 tablets per blister,100-count package, Rx Only Manufactured by Apotex Inc. Toronto, Ontario…
Reason Failed Impurities/Degradation Specifications
Class III · Low risk Terminated
Atorvastatin Calcium 20 mg, 10 tablets per blister,100-count package, Rx Only Manufactured by Apotex Inc. Toronto, Ontario…
Reason Failed Impurities/Degradation Specifications
Class III · Low risk Terminated
Atorvastatin Calcium 10 mg, 10 tablets per blister,100-count package, Rx Only Manufactured by Apotex Inc. Toronto, Ontario…
Reason Failed Impurities/Degradation Specifications
Class III · Low risk Terminated
Amlodipine besylate and Atorvastatin calcium Tablets, 10 mg/80 mg, 30 Count Bottles, Rx Only. Manufactured by Dr. Reddy's…
Reason Subpotent Drug: Subpotent atorvastatin.
Class III · Low risk Terminated
Amlodipine besylate and Atorvastatin calcium Tablets,10 mg/40 mg, Packaged in a) 30 Count Bottles (NDC: 43598-315-30) and b) 90…
Reason Subpotent Drug: Subpotent atorvastatin.
Class III · Low risk Terminated
Amlodipine besylate and Atorvastatin calcium Tablets, 10 mg/20 mg, Packaged in a) 30 Count Bottles (NDC: 43598-318-30) and b) 90…
Reason Subpotent Drug: Subpotent atorvastatin.
Class III · Low risk Terminated
Amlodipine besylate and Atorvastatin calcium Tablets, 5 mg/20 mg, Packaged in a) 30 Count Bottles (NDC: 43598-319-30) and b) 90…
Reason Subpotent Drug: Subpotent atorvastatin.
Class III · Low risk Terminated
Amlodipine besylate and Atorvastatin calcium Tablets,2.5 mg/40 mg, 30 Count Bottles, Rx Only. Manufactured by Dr. Reddy's…
Reason Subpotent Drug: Subpotent atorvastatin.
Class III · Low risk Terminated
Amlodipine besylate and Atorvastatin calcium Tablets, 2.5 mg/20 mg, 30 Count Bottles, Rx Only. Manufactured by Dr. Reddy's…
Reason Subpotent Drug: Subpotent atorvastatin.
Class III · Low risk Terminated
Amlodipine besylate and Atorvastatin calcium Tablets, 2.5 mg/10 mg, 30 Count Bottles, Rx Only. Manufactured by Dr. Reddy's…
Reason Subpotent Drug: Subpotent atorvastatin.
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